Transport of biological materials for the treatment of disease is becoming more common. These materials are often extremely temperature sensitive. Conventional shipping methods include the use of insulated containers and some form of thermal mass. One of the challenges encountered during the shipping of such temperature sensitive materials is inadvertent freezing or overheating of the materials, which may result in the effective destruction of the materials. One of the causes for excursions below and above acceptable temperature limits is inappropriate pack-out materials and procedures.
Another problem with the transport of temperature sensitive disease-treating materials is the absence of relevant data relating to the condition of the materials during transit. For example, the personnel administering the treatment has no assurance that the materials did not become too cold or too hot during transit and cannot risk using the materials due to the absence of a temperature history for the materials. Other important data can include humidity, atmospheric pressure, light exposure, location, and/or shock and vibration history.
In many cases, the transport of such biological materials can be divided into two distinct transport segments. The first transport segment begins with shipment from a laboratory or other material supplier and ends at a treatment facility. This first transport segment may include long distance air transport, which may be an international transport. The duration of this first transport segment may range from 24 to 96 hours. The second transport segment includes transport of the biological material within the treatment facility. This second segment may include removal of the temperature sensitive material from the insulated shipping container used for the first transport segment and transport to the actual point of use of the material, where the material is infused or administered to a patient. This second transport segment may range anywhere from 30 minutes to 24 hours.